TransMedics Group (TMDX) Announces Favorable OCS Heart FDA Panel Vote

April 7, 2021 8:25 AM EDT

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Late Tuesday, TransMedics Group, Inc. (Nasdaq: TMDX) announced today that after the review of TransMedics' clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration ("FDA") has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2 (Cardiovascular Devices). The panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6, with 2 abstaining, that there is reasonable assurance that the OCS Heart System is effective. The panel voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System's safety.

FDA Advisory Committees provide the FDA with independent opinions and non binding recommendations from outside medical experts. While the FDA will consider the opinions and recommendations expressed at the Advisory Committee, the FDA will make a decision regarding whether to approve the premarket approval application for the use of the OCS Heart System for donor hearts currently utilized and unutilized for transplantation after completion of its review of the application.

"This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review," said Waleed Hassanein, MD, President and Chief Executive Officer. "We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who gave our patients the gift of life by supporting organ donation. In addition, we want to thank the respected members of the Advisory Panel and the FDA review team for their thoughtful discussion and deliberations on this important PMA. We are now laser focused and looking forward to our next important business milestones planned for 2021: the scheduling the OCS Liver FDA Advisory Panel Meeting, the final readout of the OCS Heart DCD trial and the filing of the DCD Heart PMA supplement to eventually expand our OCS Heart indication into DCD heart transplantation in the U.S."

"For decades we have talked about heart transplant being supply limited. If approved by the FDA, with the use of OCS Heart System for extended criteria donors, and DCD hearts, we can access to a significantly greater suitable donor poll, said Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS Heart EXPAND Trial. "As the donor pool expands, more patients can have access to this life saving therapy. If the OCS Heart System is approved, I believe the industry will reverse its thinking and open up the 'demand' to a greater patient population that never had a chance at a new heart and a better life."

"The potential opportunity to expand the donor pool for our heart transplant candidates using the TransMedics device in select patients would be a major advance in the field of heart transplantation," said Dr. Maryjane Farr, medical director of the transplant program at Columbia University Irving Medical Center.

EXPAND and CAP Trial The OCS Heart EXPAND trial met its primary effectiveness endpoint. It showed that the use of the OCS Heart System resulted in successfully transplanting 84% - more than 8 out 10 of the extended-criteria donor hearts that are seldom used for transplant today in the U.S. using cold ischemic storage preservation. The post-transplant rate of severe Primary Graft Dysfunction was 8%, which is well below the rates reported in the literature and there were no unexpected safety findings. Patient survival at 30-days post-transplant was 97%. All-cause survival was 92% at 6 months and 87% at 12 months. Importantly, cardiac-related survival was 96% at both 6 and 12 months, these survival rates are comparable to U.S. standard heart transplant outcomes.



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